BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1932139 · Received December 8, 2010

    Report

    Report Number
    2023826-2010-01248
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 11, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).METHOD - (OTHER): LENS WORK ORDER SEARCH. RESULT - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF ONE HAPTIC TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSION - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON ATTEMPTED TO INSERT A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS AND THE HAPTIC WAS BENT. THERE WAS PT CONTACT, BUT NO INJURY. ADD'L INFO HAS BEEN REQUESTED, BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR: MODEL AND LOT NUMBER - UNK| CARTRIDGE: MODEL AND LOT NUMBER - UNK